Agendia Presents Data from the FLEX Real World Evidence Trial in Seven Posters at ASCO 2022, Showcasing the Power of Its 30,000-Patient Breast Cancer Genome Project

Data show MammaPrint^® is the first and most comprehensive FDA-cleared test for early breast cancer resulting in the ability to identify women who may be over- or under-treated if treatment decisions relied on the 21-gene assay

FLEX Trial continues to support the discovery and development of novel genomic profiles, bringing precision oncology into the clinic to improve and redefine breast cancer management

Agendia, Inc., a commercial-stage company focused on improving outcomes for breast cancer patients worldwide by providing physicians and patients with next-generation diagnostic and information solutions to inform optimized treatment decision-making, today announced it will present seven posters derived from the company’s FLEX Trial, the real-world, multicenter, prospective, observational breast cancer study at the American Society of Clinical Oncology Annual Meeting (ASCO) 2022.

One of Agendia’s posters, selected for the oral discussion session, titled Whole transcriptomic analysis of HR+ breast cancer in Black women classified as basal-type by BluePrint [Reid, S., et al.], will present findings from a racially-diverse cohort and resulting transcriptomic analyses suggesting hormone receptor-positive (HR+)/Basal tumors are biologically similar to triple-negative breast cancer (TNBC) tumors, regardless of race, demonstrating the importance of subtyping a tumor’s biology to determine optimal treatment course. BluePrint^® also identified racial disparities in the proportion of HR+/Basal tumors, showing a near doubling of such tumors among Black women, underscoring the need for diverse representation in clinical trials, a hallmark of the FLEX Trial.

“Leveraging the BluePrint assay, we are able to uncover new gene expression insights for HR+/Basal breast cancer tumors, which traditionally are more aggressive, higher grade, and disproportionally impact Black women compared to White women,” said Sonya Reid, MD, MPH, Department of Medicine, Vanderbilt University Medical Center. “The FLEX Trial’s robust collection of diverse patient genomic profiles uniquely allows for sub-studies analyses like these to take place, helping researchers better support their patients from all racial and ethnic backgrounds with further classification of breast cancer tumors.”

These data build on findings presented at San Antonio Breast Cancer Symposium 2021, also authored by Dr. Reid, that showed MammaPrint^® and BluePrint^® more robustly identify differences in more aggressive breast cancers in Black and White women beyond clinical factors, highlighting the fundamental importance of genomic classification and personalized treatment planning.

In addition, Agendia will present several sub-studies highlighting the FLEX Trial’s approach to cancer research by accelerating impactful data generation, aimed at redefining cancer care. The company believes this patient-centric design and national network of participating sites backed by Agendia will allow its investigator-initiated sub-studies to produce important results with the potential to drive science forward, like those being shared at ASCO 2022:

• Clinical implications for patients with discordant Oncotype and MammaPrint results [Socoteanu, M., et al.] recalls findings from the IMPACT trial, which demonstrated MammaPrint and BluePrint inform treatment planning and increase physician confidence. In an effort to examine consistency among genomic tests, researchers analyzed therapy implications for patients who received both results from MammaPrint and BluePrint as well as OncotypeDx within the FLEX Trial:
  • Of 722 patients, 49% were observed to have discordant results with the potential of negative clinical impact. This includes 27% who may be undertreated, 6% potentially overtreated, and 10% who may not be given the option to decrease endocrine therapy to two years based on MammaPrint Ultra Low genomic risk assessment. Of 114 concordant MammaPrint High Risk tumors, 14% were genomically classified as Basal, and likely require more aggressive chemo than typically used in estrogen receptor-positive (ER+) breast cancers.
  • Together, these analyses showed more than half the patients in this cohort were at potential risk for undertreatment or overtreatment, had they received an OncotypeDx test as a standalone test. Discordance between OncotypeDx Recurrence Scores and MammaPrint with BluePrint results, most often yields the potential for undertreatment if the Recurrence Score is relied upon for treatment decision-making, putting a significant amount of risk on the patient since undertreatment may result in an incurable metastatic recurrence.
• Whole transcriptome analysis of tumors with discordant Oncotype and MammaPrint results in the FLEX trial [Socoteanu, M., et al.] also looked at the differences in quality of results from OncotypeDx Recurrence Scores in comparison to MammaPrint results, this time by evaluating the genomic diversity within each test’s classification. The analysis found a high amount of genomic diversity within the OncotypeDx Recurrence Score Intermediate group, while conversely showing MammaPrint further classifies cases into more genomically rich and distinct categories, allowing for more precise treatment pathways based on the individual tumor.
• Investigation of a genomic signature for transcription factor MAF gene amplification and lack of bisphosphonate benefit in early breast cancer [Nasrazadani, A. et al.] provides whole transcriptome analyses suggesting breast cancer tumors with mesenchymal aponeurotic fibrosarcoma (MAF) gene amplifications – a biomarker associated with shortened survival and lack of bisphosphate benefit when related to bone metastases in breast cancer – may be identified by a unique gene expression pattern. In this study, researchers used the MammaPrint/BluePrint platform to identify a set of 57 genes that could potentially predict MAF amplification status which could enable a woman’s care team to potentially anticipate a lack of benefit from adjuvant bisphosphonate treatment. Additionally, these results show mining the complete genome more thoroughly provides expanded insights and can shed light on new biomarkers previously unknown.
• Distribution of breast cancer molecular subtypes within receptor classifications: Lessons from the I-SPY2 trial and FLEX Registry [Cha, J., et al.] proposes that the breast cancer research community drive science forward and work with the NCI’s Surveillance, Epidemiology, and End Results (SEER) Program to update its immunohistochemical (IHC) labels to avoid overlap with molecular subtype nomenclature and incorporate more modern classifications when available. Study results show the SEER Program database using IHC labels is not accurately identifying genomic subtypes via its annotations. In fact, the categorizations in the population-based registry were discordant with MammaPrint and BluePrint results in 52% of I-SPY2 Trial cases and 43% of FLEX Trial cases, emphasizing the growing importance of molecular subtyping to inform treatment and epidemiological research.
• Defining transcriptomic profiles of early-stage mucinous breast cancers: A FLEX sub study [Sivapiragasam, A., et al.] revealed although mucinous breast cancer (MuBC), a rare subtype of invasive ductal carcinoma (IDC) accounts for less than 2% of all breast cancers, it often is expected to have low clinical risk and a favorable prognosis, however new genomic testing showed half of the patients observed in the study were in fact classified as MammaPrint High Risk. Through the examination of transcriptomic profiles, the findings demonstrated MammaPrint Low Risk MuBC is biologically different from MammaPrint Low Risk IDC providing new evidence as to why there are more favorable prognoses. Results also indicated MammaPrint High Risk MuBC and High Risk IDCs are highly genomically similar and could benefit from chemotherapy, providing additional clarity to guide specific treatment among these breast cancer subtypes.
• FLEX, the 30,000 breast cancer transcriptome project: A platform for early breast cancer research using full-genome arrays paired with clinical data [Ma, C., et al.] shares data from the 38 investigator-initiated sub-studies – including five investigating racial disparities – approved within the FLEX Real World Evidence Trial (NCT03053193). Since the trial’s inception in 2017, FLEX has enrolled 10,000 patients at over 109 sites with a diverse data set designed to meet the needs of historically under-represented patients with breast cancer.

“These new findings presented at ASCO 2022 show the breadth of the FLEX research platform to identify and evaluate the many different complexities of a breast cancer biology at diagnosis that may facilitate more precise and individualized treatment recommendations,” said William Audeh, MD, Chief Medical Officer at Agendia. “Agendia’s commitment to expanding our understanding of breast cancer to improve outcomes for women with breast cancer is astounding, exemplified by the FLEX Real World Evidence Trial. FLEX has the significant potential to broaden the application of genomic information through assays such as MammaPrint, BluePrint, and new proprietary Agendia signatures, which could lead to practice-changing models within breast cancer care aimed at improved outcomes for women with breast cancer.”

Agendia will be sharing updates throughout the conference on its Twitter, Facebook and LinkedIn pages.

About Agendia

Agendia is a mission-driven, commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide. The company currently offers two commercially-available genomic profiling tests that help surgeons, oncologists and pathologists to personalize treatment for women at critical intervention points throughout their patient journey.

MammaPrint^® is a 70-gene prognostic test that, along with other clinicopathologic factors, determines a specific patient’s breast cancer recurrence risk. BluePrint^® is an 80-gene molecular subtyping test that identifies the underlying biology of an individual breast cancer to provide information about its behavior, long-term prognosis and potential response to systemic therapy. Together, MammaPrint^® and BluePrint^® provide a holistic view of the biology underlying an individual patient’s breast cancer, enabling physicians to objectively select the best treatment plan.

For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com.

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